Bristol Myers Squibb announced positive data from two separate Phase III clinical trials of the company’s checkpoint inhibitor Opdivo (nivolumab).
AstraZeneca and Daiichi Sankyo’s Enhertu helped patients with three different types of cancer live longer in trials, pointing to potential broader use of the breast cancer treatment.
FDA Rejects Merck’s 6-Week Dosing Schedule for Keytruda
Blockbusters, Checkpoint Inhibitors, Classical Hodgkin Lymphoma, Complete Response Letter, Dosing, FDA, FDA/Regulatory, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Merkel cell carcinoma, Primary Mediastinal B-Cell Lymphoma (PMBCL), Supplemental Biologics License Application (sBLA)Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
AstraZeneca announced that the company’s Brilinta (ticagrelor) hit the primary endpoint in the Phase III THALES trial in stroke.
Daiichi Sankyo is taking Seattle Genetics to court over the technology the two companies used to develop antibody-drug conjugates (ADCs) during a partnership that spanned seven years.
Oncologie Inc. announced a clinical collaboration agreement with Merck to evaluate the combination of Oncologie’s investigational drug Bavituximab – an antibody that blocks the activity of phosphatidylserine – and Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer.
Top 200 Medicines Annual Report 2019: The king of medicines
Ankylosing Spondylitits, August 2019, Autoimmune Diseases, Biologics, Biosimilars, Blockbusters, Cervical Cancer, Classical Hodgkin Lymphoma, Crohn's Disease, Esophageal Cancer, Forecasts, Gastric Cancer, Head & Neck Cancer, Hepatocellular Carcinoma, Hidradenitis suppurativa, Issue Archives, Juvenile Idiopathic Arthritis, Market exclusivity, Melanoma, Merkel cell carcinoma, Metastatic Urothelial Carcinoma (mUC), Microsatellite instability-high (MSI-H) cancer, Monoclonal Antibodies, Non-Small Cell Lung Cancer (NSCLC), Plaque Psoriasis, Primary lediastinal large B-cell lymphoma, Product Launches, Psoriatic Arthritis, Renal Cell Carcinoma (RCC), Rheumatoid Arthritis, Therapeutics, Top 200 Medicines, Ulcerative Colitis, UveitisHumira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.
Merck & Co. reported that the checkpoint inhibitor Keytruda had mixed results as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
AstraZeneca will pay up to $6.9 billion to work with Daiichi Sankyo on a hotly tipped experimental treatment for breast cancer, in a direct challenge to the world’s largest cancer drug maker Roche.